NCT05883241 Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
| NCT ID | NCT05883241 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ZetrOZ, Inc. |
| Condition | Bone Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2023-06-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.
Eligibility Criteria
Inclusion Criteria: * Have physician-diagnosed bone fracture * Are between 18-80 years of age * Report a pain score between 3-7 (range: 0-10) prior to enrolment * Report that pain from fracture negatively affects quality of life * Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study * Are deemed appropriate by their physician or by the study site physician to participate. * Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device. * Not use or initiate opioid and/or non-opioid analgesic medications. * Be willing to discontinue any other interventional treatment modalities on the affected area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound). Exclusion Criteria: * Cannot successfully demonstrate the ability to put on and take off the device. * Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions. * Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening. * Is pregnant. * Is a prisoner. * Is non-ambulatory (unable to walk). * Has a pacemaker. * Has a malignancy in the treatment area. * Has an active infection, open sores, or wounds in the treatment area. * Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia. * Has a known neuropathy (disease of the brain or spinal nerves). * Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage). * Are currently taking steroids.
Contact & Investigator
George K. Lewis, Ph.D.
PRINCIPAL INVESTIGATOR
ZetrOZ Systems
Frequently Asked Questions
Who can join the NCT05883241 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Bone Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05883241 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05883241 currently recruiting?
Yes, NCT05883241 is actively recruiting participants. Contact the research team at george@zetroz.com for enrollment information.
Where is the NCT05883241 trial being conducted?
This trial is being conducted at Trumbull, United States, Lansdowne, United States.
Who is sponsoring the NCT05883241 clinical trial?
NCT05883241 is sponsored by ZetrOZ, Inc.. The principal investigator is George K. Lewis, Ph.D. at ZetrOZ Systems. The trial plans to enroll 90 participants.